Kornimate/medical-research-clean huggingface dataset:
effects of creatine supplementation in rett syndrome

Conditions: Rett Syndrome

Summary: creatine supplementation in rtt: a randomized controlled trial rett syndrome (rtt) is a neurodevelopmental disorder characterised by apparently normal early development (stage 1 of rtt) followed by loss of purposeful hand use, distinctive hand stereotypes, slow brain growth, loss of language, respiratory irregularities, gastrointestinal disturbances, gait abnormalities, seizures, and mental retardation. these symptoms typically appear between 6 and 18 months of age (stage 2). subsequently, there is gradual stabilisation of severe mental retardation and motor compromise (stage 3). the majority (70% to 80%) of patients show mutations in the methyl-cpg-binding-protein-2 (mecp2) gene, located on chromosome xq28. mecp2 encodes a transcription repressor protein that is ubiquitously expressed in all tissues. as rtt primarily affects females, only very few males with mutations in mecp2 have been identified. mutations in mecp2 have also been identified in children with x-linked mental retardation, autism and a clinical phenotype that resembles angelman syndrome. the aim of this study is to investigate the effects of a dietary supplement on the biochemical and clinical parameter of rtt. about 80 % of labile methyl groups generated through the re-methylation cycle are used for the synthesis of creatine within the human organism. supplementation of creatine will therefore increase the availability of labile methyl groups for different methylation reactions including methylation of dna. the study will be double blind and cross-over. the patients will get creatine monophosphate (200 mg/kg/d in three dosages per day) or placebo. after 6 months and a wash-out period of 4 weeks the groups are changed for the next 6 months. all participants with rtt and mutations in mecp2 will undergo physical and neurological exam, quantitative eeg, behavioral assessment, laboratory testing, and neuropsychological evaluations. participants will have a follow-up after 3, 6, 10, 13 and 16 months (3 months after finishing the study), which will include similar assessments.


Eligibility criteria:
inclusion criteria: * rtt syndrome, diagnosed by current consensus criteria exclusion criteria: * taking supplements containing either folic acid or vitamin b12 or knowingly consuming any vitamin-fortified food items

Keywords: rett syndrome, randomized, methylation
a study of pegasys (peginterferon alfa-2a) added to nucleos(t)ide analogue treatment in participants with hbeag-negative chronic hepatitis b genotype d showing stable hepatitis b virus (hbv) deoxyribonucleic acid (dna) suppression

Conditions: Hepatitis B, Chronic

Summary: this open-label, single-arm, multicenter study will evaluate the efficacy and safety of adding pegasys (peginterferon alfa-2a) to nucleos(t)ide analogue (nas) treatment in participants with hbeag-negative chronic hepatitis b genotype d showing stable hbv dna suppression. after a 12-week lead-in period on treatment with na, participants with a hbsag decline \<0.5 log10 iu/ml will enter the add-on period to receive pegasys 180 mcg subcutaneously weekly for 48 weeks in addition to their current na treatment. follow-up will be a further 48 weeks, during which the participants will continue their na treatment.


Eligibility criteria:
inclusion criteria: * adult participants, 18 - 65 years of age * chronic hepatitis b * negative for hbeag * on monotherapy with any nucleos(t)ide analogue (na) but telbivudine at enrolment, and hbv dna persistently below 20 iu/ml for at least 12 months * hbsag \>100 iu/ml at the beginning of the lead-in phase, confirmed before addition of pegasys * showing a steady hbsag kinetic (hbsag decrease \<0.5 log10 iu/ml from week -12 to start of the add-on phase) * negative pregnancy test for women of childbearing potential * women of childbearing potential and fertile males with female partners of childbearing potential must be using reliable contraception during and for 3 months after the add-on phase exclusion criteria: * coinfection with hepatitis a virus (hav), hepatitis c virus (hcv), hepatitis d virus (hdv), human immunodeficiency virus (hiv) * evidence of decompensated liver disease (child-pugh \>/=6) * history or other evidence of a medical condition associated with chronic liver disease (e.g. hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposure) * known hypersensitivity to peginterferon alfa-2a * pregnant of breastfeeding women * evidence of alcohol and/or drug abuse * history of severe psychiatric disease, especially depression * history of immunologically mediated disease * history or evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease * history or evidence of severe pulmonary disease associated with functional limitations * history of severe cardiac disease * history of severe seizure disorder or current anticonvulsant use * evidence of an active or suspected cancer or a history of malignancy (other than basocellular carcinoma or in situ cervical carcinoma) within 5 years prior to study entry * history of having received any systemic anti-neoplastic (including radiation) or immunomodulatory (including systemic corticosteroids) treatment \</= 6 months prior to the first dose or the expectation that such a treatment will be needed at any time during the study * history or other evidence of severe retinopathy
a4250, an ibat inhibitor in pediatric cholestasis

Conditions: Pediatric Cholestasis

Summary: this study will evaluate a4250 (ibatinhibitor) as a treatment option in pediatric patients with chronic cholestasis with main emphasis on safety evaluation and on effects on pruritus

the primary aims of this phase ii exploratory study in patients treated with a4250 due to cholestasis induced pruritus are to: * assess the safety and tolerability of a4250, orally administered first as a single dose and then during a four week treatment period, as determined by the occurrence of treatment-emergent saes * explore changes in serum total bile acids after a four week treatment period secondary safety aims include assessment of the safety and tolerability of a4250, orally administered first as a single dose and then during a four week treatment period, as determined by the occurrence of treatment-emergent aes and changes in safety parameters including laboratory tests and vital signs secondary efficacy aims are to: * demonstrate the efficacy of a4250, orally administered during a four week treatment period, on liver biochemistry variables and on pruritus parameters * evaluate the pharmacokinetic properties of a4250 orally administered first as a single dose and then after a four week treatment period * evaluate changes in vas-itching score after a four week treatment period

Eligibility criteria:
inclusion criteria: * diagnosis of pruritus due to chronic cholestasis based on history and investigator judgment. this will include but will not be restricted to patients with progressive familial intrahepatic cholestasis (pfic), alagille syndrome (algs), biliary atresia and sclerosing cholangitis exclusion criteria: * any condition that in the opinion of the investigator constitutes a risk for the patient or a contraindication for participation and completion of the study, or could interfere with study objectives, conduct, or evaluations * clinical or biochemical signs of decompensated liver disease * liver transplantation
compari̇son of heart fai̇lure pati̇ents and healthy people i̇n balance and gai̇t parameters

Conditions: Heart Failure,Balance

Summary: we aimed to show the difference between balance and gait parameters in heart failure and healthy individuals.

heart failure is the inability of the heart to pump a sufficient amount of blood into our body. the reason is usually the decrease in the contractile capacity of myocardium due to decreased coronary blood flow. symptoms and symptoms may be quite diverse in the underlying pathophysiology of heart failure, which is usually the only type. as a result of heart failure; problems such as dyspnoea, anemia, peripheral edema, peripheral muscle involvement and decreased muscle mass, confusion, sleep disorder, dementia, various cardiac symptoms and renal failure can be seen. balance body with minimal muscle activity in static or dynamic position on the support base is to maintain the center of gravity. patients with heart failure may have decreased postural control, exercise intolerance, breathing problems, and decreased cognitive function. gait analysis, evaluation of neuro musculoskeletal system functions and interpretation of results with numbers and graphs. gait analysis is an analysis method that plays a role in many cases of clinical diagnosis and follow-up. heart failure is characterized by a significant reduction in walking distance, which leads to reduced quality of life. in a study conducted in heart failure, it is stated that gait velocity is a determinant of one year mortality and hospitalization, and should be considered for clinical evaluations and prognosis. all these causes of heart failure in chronic disease groups defined considering it is important to investigate the balance and gait parameters. this study will show the difference between the balance and walking parameters in heart failure according to the healthy participants.

Eligibility criteria:
inclusion criteria: * ejection fraction \<40% or less, * without acute decompensation, * no revascularization in the last six months, * the drug has been stable for the last four weeks, * accepts participation in the study, * coopere, * newyork heart association -nyha class ii- iii * patients with heart failure who are amputated without support or assistive devices will be included in the study. exclusion criteria: * neurological, cognitive or orthopedic diseases that affect the measurements, * severe respiratory disease (fev1 \<35%), * bnp\> 100pg / ml and above, * acute infection, * resting heart rate above 140 beats / min, * dementia, * having a bmi\> 35 or above, * individuals with other chronic diseases that may affect their balance and walking will not be included in the study.

Keywords: gait parameters, heart failure,balance,gait,cognition,functional capacity,muscle strength
impact of polycyclic aromatic hydrocarbons (pah) on in vitro fertilization

Conditions: Infertility

Summary: the main objective of this study is to highlight a relationship between exposure to pahs, genotoxic effect biomarkers on spermatozoa and follicular cells, as well as embryonic quality and embryo implantation rates at a given time. ivf attempt. this study therefore analyzes the possibility of using this exposure biomarker as a reliable means of evaluating the quality of gametes in order to estimate the chances of success in ivf.

objective assessment of the effect of environmental and occupational factors on fertility is difficult to establish due to the lack of relevant exposure biomarkers for reporting multi-exposures. the main objective of this study is to highlight a relationship between exposure to pahs, genotoxic effect biomarkers on spermatozoa and follicular cells, as well as embryonic quality and embryo implantation rates at a given time. ivf attempt. this study therefore analyzes the possibility of using this exposure biomarker as a reliable means of evaluating the quality of gametes in order to estimate the chances of success in ivf. subsequently, the results of this study will make it possible to personalize and evaluate the effectiveness of the preventive measures put in place upstream of the mpa route by allowing to identify a relationship between pah exposure and sperm dna gamete quality in humans, serum amh concentration and ovarian response to gonadotropic stimulation for ivf in women. to highlight a relationship between individual exposures to complex pah mixtures and infertility. the methodology based, on the feminine side, on the analysis of follicular cells makes it possible to study cells close to female gametes within the cumulo-oocyte complex, without losing the chance of pregnancy for the couple.

Eligibility criteria:
inclusion criteria: * couples whose wife is under 36 and the man under 45 at the time of ivf * regular cycles of 27 to 33 days in women * management of classical ivf (without the use of micro-sperm injection) * 1st or 2nd attempt of ivf * signature of informed consent by both partners of the couple * affiliation to a social security scheme or equivalent for both partners of the couple. exclusion criteria: * refusal to participate in the study of one or both members of the couple * no fluency in french * history likely to alter the ovarian reserve, endometriosis * uterine or systemic antecedents, likely to affect implantation * andrological antecedents likely to alter fertilization rates * history of chemotherapy / radiotherapy * positive plasma viral load for hiv, hcv or hbv in the year prior to inclusion in one of the members of the couple
vaginal elasticity assessment before and after brachytherapy/pelvic radiation

Conditions: Radiation Injuries

Summary: female patients with either uterine/cervical malignancies will be evaluated for vaginal elasticity using vaginal tactile imaging both before and after radiation treatment.

patients will be recruited and sign a consent form. the patients included are patients with either uterine/cervical malignancies. each participant undergoes radiation treatment either as primary or complementary treatment. assessment of vaginal elasticity via vaginal tactile imaging will be performed at 3 different points: * before the first treatment session (baseline). * after the last session of laser treatment. * 3 months post final treatment. every patient will serve as her own control. demographic, gynecologic and obstetric history will be obtained from patients' electronic files.

Eligibility criteria:
inclusion criteria: * any woman undergoing either brachytherapy or pelvic radiation treatment as primary or complementary treatment for a cervical/uterine malignancy. exclusion criteria: * women that are not in the age range. * women with massive vaginal bleeding. * women after pelvic exenteration.
integrated ba and hiv rr counseling for msm with stimulant abuse

Conditions: Stimulant Abuse; HIV Prevention; Substance Abuse

Summary: this study seeks primarily to test, in a two-arm randomized controlled trial (rct), the efficacy of project impact, an intervention that integrates behavioral activation (ba) with hiv risk reduction (rr) counseling for hiv-uninfected men who have sex with men (msm) with stimulant use disorder at risk for hiv via sexual behavior. hiv-uninfected msm with a diagnosis of stimulant use disorder will be equally randomized to one of two study arms: (1) the project impact intervention, ba-rr counseling, which lasts ten sessions; and (2) the standard of care (soc) comparison condition, including two equivalent sexual risk-reduction counseling sessions. participants will be followed for one year post-randomization, with assessments at months four, eight, and 12.

project impact targets both stimulant use and sexual risk reduction in effort to help individuals relearn how to enjoy safe but pleasurable activities. the intervention integrates ba, an evidence-based cognitive behavior therapy for improving mood and increasing activity, incorporated with rr counseling aimed to reduce risky sexual practices, and potential hiv acquisition. this rct is a two-arm efficacy trial, comparing the project impact intervention with a soc arm. all participants will receive hiv testing, pre-/post-test risk reduction counseling, oral swab toxicology test at baseline and 12 months, assessment of interest/indication for pre-exposure prophylaxis (prep) per center for disease control guidelines, and active referral to local prep services as standard-of-care. finally, the rct will integrate resource utilization and cost-effectiveness analyses to examine cost efficiency of the project impact intervention as a component of data analysis.

Eligibility criteria:
inclusion criteria: * age 18 or older * assigned male at birth * hiv-uninfected verified via rapid hiv test * self-reports in the past four months: cas receptive or insertive with a cisgender male sexual partner, while using stimulants and without the protection of pre-exposure prophylaxis (prep)\* * able to read, speak, and understand english * willing and able to provide informed consent exclusion criteria: * does not live in the greater boston or miami areas, or will move away from boston or miami within the next 12 months * self-reports being 100% adherent to prep in the last four months * unable to provide informed consent due to severe mental or physical illness, or substance intoxication at the time of interview * discovery of active suicidal ideation at the time of interview (participants will be referred immediately for treatment, but may join the study once resolved)- * involvement in any other hiv prevention study that may interfere with the ability to test major study outcomes (e.g. another sexual risk reduction intervention or prep adherence intervention)

Keywords: risk reduction crystal methamphetamine cocaine stimulant abuse hiv behavioral activation
e. faecalis prevalence in primary and secondary endodontic infections: a pre-post microbial analysis following chemo-mechanical preparation

Conditions: Apical Periodontitis

Summary: post-treatment apical periodontitis is a fairly prevalent condition frequently caused by a persistent endodontic infection due to failure of the endodontic treatment. microbial species in treated or untreated root canals were found to be different, with the former being less diverse and mainly characterized by gram positive, facultative anaerobes bacteria than the latter. enterococcus faecalis is the most frequently detected species in root-filled teeth in many studies (zhang et al., 2015). in fact, e. faecalis retains many virulence factors allowing adhesion to host cells and extracellular matrix, tissue invasion and damage through toxins release, as well as the ability to survive even in harsh environmental conditions. further studies are needed to clarify e. faecalis prevalence among the different forms of pulpal and periapical lesions as well as its correlation with clinical symptoms.


Eligibility criteria:
inclusion criteria: * between the ages of 18 and 70; * good systemic health. * patients in need of an endodontic treatment/retreatment exclusion criteria: * taking antibiotic therapy in the previous 3 months; * presence of communication between the canal system and the oral cavity; * teeth that are not perfectly isolated; * teeth with probing depth \>4 mm with positive bop.
antrum size, glucagon-like peptide 1 levels and glycemic control after sleeve gastrectomy in morbid obese diabetic adolescents

Conditions: Adolescent Obesity

Summary: childhood obesity can adversely affect every organ and often has serious consequences. compare the effect of transection at 2cm vs at 5cm from the pylorus during laparoscopic sleeve gastrectomy on the postoperative weight loss, glucagon-like peptide 1 levels and the glycemic control in morbid obese diabetic adolescents.

this was a retrospective sub-analysis included 18 type 2 diabetic morbidly obese adolescents of both genders from a larger study (performed on 67 patients between december 2014 and december 2015) conducted at pediatric surgery unit, surgical department, egypt. they were divided in 2 groups, done by 2 surgeons, group a (8 patients) the first stable line was at 2 cm from the pylorus, and group b (10 patients) at 5 cm from the pylorus.

Eligibility criteria:
inclusion criteria: * adolescent, children (more than 12 years or less than 20 years), with bmi of at least 40 kg/m2, or 35 kg/m2 with an associated co-morbidity (e.g. hypertension, diabetes, dyslipidemia, obstructive sleep apnea, left ventricular hypertrophy, nonalcoholic steatohepatitis, orthopedic problems). those with failure to achieve clinically significant weight loss (10% of baseline body weight) despite strict participation for at least 6 months in a formal weight management program were included in the study. exclusion criteria: * adults, children (less than 12 years or more than 20 years) or their family who do not understand risks and benefits of the intervention, adolescents who are not autonomously motivated to consider operation, those have unrealistic expectations for results of the surgical intervention, or their parents, families or patients who cannot strictly comply with the postoperative nutritional recommendations and long-term medical and nutritional monitoring, presence of a medically correctable cause of obesity (relative contraindication), existence of a medical, psychiatric, or cognitive condition as attention deficit hyperkinetic disorders (adhd) which may impair the ability of patient to assent to surgery or to adhere to postoperative dietary and medication regimen (relative contraindication), illicit substance abuses in preceding year, lactating, pregnant, or plans for pregnancy in upcoming 2 years and patients refuse to participate were excluded.

Keywords: laparoscopic sleeve gastrectomy obesity adolescent glucagon-like peptide 1 glycemic control diabetes
sirtuin-1 and advanced glycation end-products in postmenopausal women with coronary disease

Conditions: Coronary Artery Disease Progression

Summary: higher consumption of fruits and vegetables promote greater availability of phenolic compounds and these compounds were associated with vascular health. quercetin, a phenolic compound, is the most abundant natural antioxidant belonging to the group of flavonoids. quercetin improved lipoprotein metabolism, had antioxidant capacity, produced vasodilating substances in the vascular endothelium and reduced platelet aggregability. likewise, statins are medications known to reduce cardiovascular events in women with coronary disease by reducing serum ldl-cholesterol. therefore, a number of metabolic pathways are responsible for vascular health. the serum concentration and gene expression of sirtuin 1 (sirt1) and rage soluble (srage) are directly associated with vascular protection. this study will analyse the influence of atorvastatin and quercetin on serum concentrations and gene expression of sirt1 and srage in postmenopausal women with stable coronary artery disease.

higher consumption of fruits and vegetables promote greater availability of phenolic compounds and these compounds were associated with vascular health. quercetin, a phenolic compound, is the most abundant natural antioxidant belonging to the group of flavonoids. quercetin improved lipoprotein metabolism, had antioxidant capacity, produced vasodilating substances in the vascular endothelium and reduced platelet aggregability. likewise, statins are medications known to reduce cardiovascular events in women with coronary artery disease (cad) by reducing serum ldl-cholesterol. therefore, a number of metabolic pathways are responsible for vascular health. the serum concentration and gene expression of sirtuin 1 (sirt1) and rage soluble (srage) are directly associated with vascular protection. this study will analyse the influence of atorvastatin and quercetin on serum concentrations and gene expression of sirt1 and srage in postmenopausal women with stable coronary artery disease and also the correlation between the changes in serum concentration of sirt1 and srage and the changes in lipid profile, inflammatory biomarkers and sex hormones in response to these drugs. this is a 60-day randomized, double blind, placebo-controlled study in 60 postmenopausal women with cad, divided into three groups with 20 women each: group 1 - quercetin (500 mg / day); group 2 - atorvastatin (80 mg / day): group 3 - control.

Eligibility criteria:
inclusion criteria: * postmenopausal women, * angiographic documented coronary artery disease, * stable coronary artery disease exclusion criteria: * bmi \<18,1 kg/m2, * smoking, * hypo or hyperthyroidism, * rheumatic disease, * use of alcohol, * hepatic failure, * renal failure * hormone replacement therapy * use of insulin

Keywords: coronary artery disease sirtuins receptor for advanced glycation end products women quercetin atorvastatin